COMPANY:

Personalis

P=Obs | N=814 | TRACERx (NCT01888601) | "Personalis...announced findings presented this week at the European Society of Medical Oncology Congress...In the first of these studies, Professor Charles Swanton and his colleagues...analyzed over 400 non-small cell lung cancer (NSCLC) patients from their TRACERx lung cancer study, using the NeXT Personal assay...A high percentage of these landmark detections (42%) occur in the ultrasensitive range (less than 80 ppm) enabled by NeXT Personal...In the second abstract, Dr. Rodrigo Toledo...presented data on a large cohort of over 200 late-stage cancer patients on immunotherapy profiled using the NeXT Personal assay, significantly expanding on the initial cohort first presented earlier this year. The study was unique in having a validation set of patients and it demonstrated that patients who had a significant decrease in ctDNA levels in response to immunotherapy had significantly longer overall survival than those who did not."

"Personalis and Tempus AI...they are expanding their commercial relationship, with Tempus investing approximately $36 million into Personalis and accelerating its commercialization efforts for Personalis' minimal residual disease test."

"Myriad Genetics, Inc...announced that they have entered into an agreement to cross-license patent estates covering tumor-informed approaches to detect minimal residual disease (MRD). The agreement helps solidify each company’s freedom to operate in the MRD market and broadens patient access to the benefits of MRD testing."

"Personalis, Inc...announced that the company has filed a second patent infringement suit against Foresight Diagnostics Inc. Personalis is seeking injunctive relief and monetary damages. This suit brings the total number of patents that Personalis alleges Foresight Diagnostics has infringed to seven."

"Personalis, Inc...announced...that data presented at the American Society for Clinical Oncology (ASCO) oral podium talks in Chicago, IL demonstrated that the Personalis NeXT Personal test had exceptional detection rates and performance for early-stage breast cancer and immunotherapy monitoring. The NeXT Personal test is the first of a new class of ultra-sensitive liquid biopsy tests designed to detect the earliest traces of cancer recurrence and monitor a patient’s response to therapy. The test can detect circulating tumor DNA (ctDNA) down to an ultra-sensitive range (<100 parts per million of ctDNA) and the data presented as ASCO highlights the clinical importance of this approach."

"Tempus...today announced the clinical launch of its minimal residual disease (MRD) test portfolio, including Tempus’ xM test and the xM (NeXT Personal Dx) test by Personalis. The portfolio features both a tumor-naïve assay and a tumor-informed assay that are designed to help detect residual disease or early cancer recurrence and monitor for immunotherapy treatment response, providing valuable insights to inform patient management strategies. The addition of both assays further complements Tempus’ comprehensive testing portfolio....xM was developed using the company’s multimodal database and advanced machine learning algorithms to accurately classify tumor fragments from non-tumor fragments, enhancing the precision of MRD calls."

"Personalis, Inc...announced...that two podium presentations and multiple posters featuring data for the company’s NeXT Personal® whole genome-based, tumor-informed assay for ultra-sensitive ctDNA detection will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, which convenes from May 31-June 4, 2024, in Chicago, Illinois."

"Personalis, Inc...announced today that a podium talk and multiple abstracts featuring data for the company’s NeXT Personal whole genome-based, tumor-informed assay for ultra-sensitive ctDNA detection will be presented at the American Association for Cancer Research (AACR) Annual Meeting, taking place in San Diego, California, April 5-10, 2024."

"Personalis, Inc...today announced a new publication validating the company’s NeXT Personal test, an ultra-sensitive, tumor-informed circulating tumor DNA (ctDNA) assay. NeXT Personal is designed to help detect minimal residual disease (MRD), monitor therapy response, and identify recurrence with high analytical sensitivity and accuracy, enhancing the decision-making process and ultimately improving patient outcomes in the ongoing battle against cancer....In the analytical validation study published in Oncotarget, scientists from Personalis evaluated NeXT Personal by testing samples from over 120 patients across nine cancer types and paired tumor and normal cell lines. The NeXT Personal technology leverages whole genome sequencing (WGS) and advanced noise suppression with NeXT SENSE technology to identify a unique genetic signature derived from a patient’s tumor based on up to ~1,800 variants."

"Personalis, Inc...unveiled an alliance through which Personalis will expand its pharmaceutical service offerings by distributing ClearNote’s cutting-edge epigenomic 5-hydroxymethylcytosine (5hmC) platform...The partnership marks a pivotal moment in cancer research, leveraging the strengths of both companies to offer unparalleled solutions in the biopharmaceutical industry."

"Personalis, Inc...today announced it has received a final Medicare coverage determination for its NeXT Dx ultra-comprehensive tumor genomic profiling assay, providing access for the nation’s 66 million Medicare and Medicare Advantage beneficiaries....NeXT Dx analyzes a tumor’s entire exome (DNA) and transcriptome (RNA) to uncover deeper insights into therapy selection, including RNA-based fusions and advanced biomarkers that smaller panels might miss, such as tumor mutational burden (TMB) and microsatellite instability (MSI). In addition, NeXT Dx utilizes paired tumor and non-tumor samples to report more accurate results."

"Personalis, Inc...and Tempus Labs, Inc...announced a strategic collaboration to co-commercialize NeXT Personal® Dx, Personalis’ whole genome-based liquid biopsy laboratory developed test (LDT) for detection of molecular residual disease (MRD) and recurrence in cancer. NeXT Personal Dx is a leap forward in tumor-informed approaches, setting the new standard in performance of MRD tests with unprecedented sensitivity and high specificity. The test was launched by Personalis in October of this year."

"Myriad Genetics, Inc...and Personalis, Inc...announced a non-exclusive collaboration through which Myriad will market the Personalis®ImmunoID NeXT ultra-comprehensive biomarker discovery platform to its pharmaceutical partners who use the MyRisk® Hereditary Cancer Test, BRACAnalysis CDx® and/or MyChoice® CDx cancer tests."

"Personalis, Inc...announced...the launch of the Early Access Program for NeXT Personal Dx, a tumor-informed, whole genome-based liquid biopsy laboratory developed test (LDT) for detection of molecular residual disease (MRD) and recurrence in cancer. Designed to help oncologists detect cancer recurrence earlier and aid in treatment decision-making, NeXT Personal Dx is poised to reshape the clinical use of MRD testing by delivering unmatched sensitivity down to the level of one circulating tumor DNA (ctDNA) molecule in a million."

"Personalis, Inc...announced the presentation of initial findings from its work with the groundbreaking TRACERx lung cancer study, marking a substantial advancement in lung cancer circulating tumor DNA (ctDNA) detection and management. The Personalis NeXT Personal cancer assay, created to detect and monitor residual and recurrent disease (MRD), demonstrated significantly improved detection rates for early-stage lung cancer, including lung adenocarcinoma (LUAD), one of the most common and challenging subtypes of non-small cell lung cancer (NSCLC) to identify in blood samples."

"Personalis, Inc...announced that a late-breaking abstract featuring data for the company’s NeXT Personal® whole genome-based, tumor-informed assay for ultra-sensitive ctDNA detection, has been accepted and selected for a proffered paper presentation at the 2023 European Society for Medical Oncology (ESMO) Congress, on October 21 in Madrid, Spain."

"Personalis, Inc...announced that the company has filed a second patent infringement suit against Foresight Diagnostics Inc. Personalis is seeking injunctive relief and monetary damages. This suit brings the total number of patents that Personalis alleges Foresight Diagnostics has infringed to seven...The additional suit, filed in the U.S. District Court for the District of Colorado, alleges that Foresight improperly based its solid tumor minimal residual disease (MRD) approach on technology already patented by Personalis."

"Personalis, Inc. (Nasdaq: PSNL) today announced it will present new clinical data as scientific posters at the American Society of Clinical Oncology (ASCO) Annual Meeting 2023, which convenes from June 2-6, 2023, in Chicago, Ill....At ASCO, Personalis will present data from two retrospective clinical studies that demonstrate a breakthrough in ctDNA detection sensitivity."

"Personalis, Inc...and Ono Pharmaceutical Co., Ltd. today announced they have entered into a collaborative agreement to examine the efficacy and safety of nivolumab, an immune checkpoint inhibitor, for resectable rectal cancer with mismatch repair deficiency (dMMR). As part of the collaboration on the VOLTAGE-2 study, an exploratory analysis will be conducted to evaluate specific biomarkers such as minimal residual disease (MRD) status that may have prognostic or predictive value for patient care. Under the agreement, National Cancer Center Hospital East (NCCHE) will recruit patients and conduct the clinical trial, Ono will provide nivolumab, and Personalis will perform MRD and biomarker testing."

"Personalis, Inc...announced it has partnered with the Academic Breast Cancer Consortium (ABRCC) and Criterium to carry out a prospective clinical trial, B-STRONGER-1 (Breast Cancer-Minimal Residual Disease Detection and Therapy Monitoring in Patients with Early Stage TNBC-Phase I), to evaluate the clinical performance of the NeXT Personal^® test for detecting minimal residual disease (MRD) during and after treatment and recurrent cancer in patients with early-stage resectable triple-negative breast cancer (TNBC)."

"Personalis, Inc....Cancer Research UK’s Cancer Research Horizons, University College London (UCL), and the Francis Crick Institute...announced a collaboration to deploy NeXT Personal, a personalized liquid biopsy-based research assay, for the TRACERx study, a groundbreaking lung cancer initiative funded by Cancer Research UK."

"The data highlights the power of the company’s highly-discerning technologies that both characterize and monitor cancer, including initial research findings from a collaboration with University Medical Center Hamburg-Eppendorf (UKE) and its new Fleur-Hiege Center for Skin Cancer Research, where Dr. Klaus Pantel, Dr. Christoffer Gebhardt, and team are using NeXT Personal® to track tumor response to immunotherapy (IO) in patients with melanoma, with the aim of gathering evidence to advance the use of ultra-sensitive minimal residual disease (MRD) detection in routine clinical practice for IO therapy monitoring."

"Personalis...announced it will continue its collaboration with AstraZeneca...to explore ultra-sensitive molecular residual disease (MRD) measurement, including clinically relevant and personalized variant tracking, for clinical research and drug development...As part of the collaboration, Personalis’ NeXT Personal assay for liquid biopsy will aim to provide ultra-sensitive measurement of MRD, on-treatment therapy resistance tracking, and better differentiation between responders and non-responders, as well as investigate the underlying mechanisms driving cancer."

"Personalis, Inc...announced a collaboration with UC San Francisco (UCSF) that will deploy a personalized liquid biopsy-based research use only (RUO) assay for a study of patients with colorectal cancer. The research efforts will use Personalis’ NeXT Personal™ assay to evaluate circulating tumor DNA (ctDNA)-based signatures associated with treatment response and adverse events in a cohort of late-stage colorectal cancer patients receiving capecitabine together with pembrolizumab and bevacizumab."

"Personalis, Inc...announced that the company will share data resulting from expanded features of its NeXT Platform® at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, November 8-12 in Boston, with three abstracts that highlight advanced R&D applications of next-generation sequencing (NGS) in immuno-oncology...The company will present the following posters at SITC2022, as well as with customers including the Parker Institute for Cancer Immunotherapy (Abstracts 559 and 587) and Geneos Therapeutics (Abstracts 691 and 692)."

"Personalis, Inc...has joined with Duke University and Olink Proteomics AB to form a research collaboration to study the effects of immunotherapy on advanced gastroesophageal cancer. Specifically, the collaboration will focus on identifying composite biomarkers—those that integrate multiple biological entities into a single readout—to help guide therapeutic decision making...Personalis’ NeXT Personal assay will be used to analyze circulating tumor DNA (ctDNA) collected from patients in order to profile and accurately track molecular residual disease (MRD) over the course of therapy."

"Personalis, Inc...announced...it has filed an amended complaint against Foresight Diagnostics. The amended complaint asserts a newly-issued patent in Personalis’ growing intellectual property portfolio relating to detection of molecular residual disease (MRD)...Personalis’ patent portfolio protects its groundbreaking work in whole genome sequencing to identify mutations that indicate the continued presence or recurrence of cancer with an unprecedented part-per-million sensitivity, which its recently-launched MRD solution, NeXT Personal, is uniquely designed to achieve."

"Personalis, Inc. has announced a collaboration with BC Cancer to deploy a personalized liquid biopsy-based research use only (RUO) assay for a study of patients with colorectal and pancreatic cancers. The research efforts will deploy Personalis’ NeXT Personal, which has demonstrated high sensitivity for detecting circulating tumor DNA (ctDNA) from a patient’s blood sample, to determine the best time to draw blood for ctDNA sampling for molecular residual disease (MRD) detection. MRD describes a very small number of cancer cells that remain in the body during or after treatment."

"Personalis, Inc...announced today that it filed a lawsuit against Foresight Diagnostics Inc. for infringement of Personalis’ U.S. Patent Nos. 10,450,611, 11,299,783, and 11,384,394. These patents are part of Personalis’ intellectual property portfolio in the field of whole genome-enabled, tumor-informed molecular residual disease (MRD) testing...NeXT Personal is purpose-built to accurately detect MRD in patient samples with low overall ctDNA, which is particularly important for cancers that have low shedding or low mutational burden, such as breast and prostate cancers, or soon after resection."

"Personalis, Inc...has added another patent family to its molecular residual disease (MRD)-related IP portfolio, with priority to January 2013. US Patent No. 11,384,394 describes the detection of MRD and recurrence by using whole genome sequencing of a patient’s tumor to identify variants for a personalized liquid biopsy assay...As with recently issued US Patent 11,299,783, the ‘394 patent covers many elements of Personalis’ NeXT PersonalTM platform, including that it describes a highly sensitive measurement of tumor burden with simultaneous tracking of up to thousands of tumor variants, both tumor-informed and prespecified, in a single panel design."

"Evaxion Biotech A/S...and Personalis....announced today that Evaxion will deploy Personalis’ ImmunoID NeXT Platform in a Phase 2b trial to evaluate the efficacy and safety of Evaxion’s personalized cancer immunotherapy EVX-01. The study will combine EVX-01, a neoepitope-targeting immunotherapy based on Evaxion’s proprietary PIONEER^® AI technology, with KEYTRUDA^® (pembrolizumab) for the treatment of patients with metastatic melanoma."

"Personalis, Inc...announced the publication of its study titled, 'A machine learning algorithm with subclonal sensitivity reveals widespread pan-cancer human leukocyte antigen loss of heterozygosity,' in Nature Communications...This study demonstrates DASH’s ability to sensitively detect subclonal events in samples with low tumor purity, enabling comprehensive profiling of widespread HLA LOH across tumor types."

"Personalis, Inc...announced the issuance of a key US Patent related to its industry-leading minimal residual disease (MRD) and recurrence platform, NeXT Personal...The patent, US Patent No. 11,299,783, entitled 'Methods and Systems for Genetic Analysis,' was issued on April 12, 2022. The ‘783 patent claims novel methods for a partially personalized assay, combining both tumor-informed and prespecified (tumor naïve) content. Tumor-informed methods can provide high sensitivity for detection of MRD."

"Personalis, Inc...announced its co-authorship of a study with Merck KGaA, Darmstadt, Germany, a leading science and technology company, to be presented during the American Association for Cancer Research Annual Meeting 2022 from April 8-13, 2022...'Working with Merck KGaA, Darmstadt, Germany, and leveraging the combination of transcriptome and exome-based data generated by the ImmunoID NeXT Platform®, we were able to explore promising, integrative approaches to complementing the previously demonstrated classification method for colorectal cancer'."

"Personalis, Inc...announced it is presenting new data in scientific posters at the American Association for Cancer Research (AACR) Annual Meeting 2022, which will be held in-person and online, April 8-13, 2022....The NeXT Liquid Biopsy platform monitors tumor variants and discovers novel mutations in the plasma, through analysis of tumor, normal and plasma samples from the same patient."

"Personalis, Inc...announced a strategic collaboration with the Moores Cancer Center at University of California San Diego Health, a National Cancer Institute-designated Comprehensive Cancer Center, to support clinical diagnostic testing in patients with advanced solid tumors and hematological malignancies. The collaboration will bring Personalis’ leading comprehensive genomic tumor profiling test to UC San Diego health care professionals and their cancer patients to help guide FDA-approved therapy decisions, as well as clinical trial treatment options."

"Personalis...announced the launch of NeXT Personal, a next-generation, tumor-informed liquid biopsy assay designed to detect and quantify molecular residual disease (MRD) and recurrence in patients previously diagnosed with cancer. NeXT Personal delivers industry-leading MRD sensitivity down to the 1 part-per-million range, an approximately 10- to 100-fold improvement over other available technologies. This enables earlier detection across a broader variety of cancers and stages, including typically challenging early stage, low mutational burden, and low-shedding cancers."

"Personalis, Inc...today announced that the company will participate in the Society for Immunotherapy of Cancer (SITC) Annual Meeting, November 12-14, including online poster presentations and online industry sponsored symposium...The company will showcase the Personalis NeXT Platform® which enables comprehensive analysis of both a tumor and its immune microenvironment from a single sample. The NeXT Platform can be used to investigate the key tumor and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays into one and maximizing the biological information that can be generated from a precious tumor specimen."

"Personalis, Inc...announced the latest expansion of the Personalis NeXT Platform® adding several new features that are key to the understanding of the interactions between the tumor and the immune system and how they may influence a cancer patient’s response to therapy...The new and improved features include:...InfiltrateID™, a sophisticated analytics module that leverages the augmented gene expression data from the NeXT Transcriptome™ to detect the presence of eight immune cell populations within a tumor sample...RepertoireID™ now incorporates the characterization of the B-cell receptor repertoire, including the computing of isotype makeup, as a complement to the previously released T-cell receptor repertoire feature...SHERPA™, further enhancing the performance of Personalis’ leading pan-allelic neoantigen prediction algorithm..."

"Personalis, Inc...announced the issuance of two key US Patents related to its high-performance, exome-wide liquid biopsy platform, NeXT Liquid Biopsy...The first patent, US Patent No. 11,142,802, entitled 'Methods for Using Mosaicism in Nucleic Acids Sampled Distal to Their Origin', issued on October 12, 2021...The second patent, US Patent No. 11,155,867, entitled 'Methods and Systems for Genetic Analysis', issued on October 26, 2021."